The recent release of the new EU guidance reinforces the role that software in many instances, will be classified as medical devices / IVDs (In Vitro Diagnostics) in a high-risk class. Refer to the details of this new guidance in this publication “MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR”.
Once the enforcement of this guidance comes into effect, it will have significant impact on the emerging digital health industry. The impact will be both in terms of the requirements regarding the quality management system and the development process. However, it will be more importantly a demand for clinical evidence from a Market Access perspective.
From the MDR regulation, Rule 11 is critical for understanding the classification of Medical Device Software (MDSW):
Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:
death or an irreversible deterioration of a person's state of health, in which case it is in class III; or
a serious deterioration of a person's state of health or a surgical intervention, in which case it
is classified as class IIb.
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.
All other software is classified as class I.
Solutions with a therapeutic or diagnostic purpose will be classified as IIa. However, many solutions that are used in chronic diseases, where faulty medical advice could lead to temporary or permanent deterioration of a person’s health, will be categorized as class IIb or III.
Would a device that tracks for physical activity with a purpose (therapeutic) to motivate a heart failure to exercise be considered class 3, since wrong advice could have permanent deterioration of health?
Even if a product is only within class IIa, clinical evidence should be used to demonstrate the value of the technology in justifying its benefit (risk-ratio to be placed on the market). Nevertheless, proving the value of digital solutions is not as straight forward as with traditional medical devices / drugs. More about this will be discussed in our future blogposts.
Besides the additional dimensions required by payers, the key-message to a digital health company is that the evidence requirements for regulatory purposes, will to a high degree align with those of payers. Evidence that will satisfy the requirements of a qualified payer / HTA will most certainly fulfill the requirements for the CE-mark.
In Germany for example, the new legislation for reimbursement of digital health will be managed by Bfarm which has caused some controversy since they are not an HTA organization. We expect that this will show that they will expect to see well designed clinical trials according to the MDR, as a pre-requisite. As such, it will not be an easy way to reimbursement. Read more about it in this blog.
For those interested in the methods of developing evidence for digital health solutions, we would recommend this prior blog and the associated webinar. Also, feel free to share your comments for this blog on the LinkedIn post.